CARNITOR 1G SOLUTION FOR INJECTION

Active substance: LEVOCARNITINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Carnitor 1g Solution for Injection
(L-carnitine inner salt)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours
- If any of the side effects get serious, or you notice any side effects not listed in this leaflet
please tell your doctor or pharmacist
- In this leaflet Carnitor 1 g Solution for Injection will be called Carnitor injection.
In this leaflet:
1. What Carnitor injection is and what it is used for
2. Before you are given Carnitor injection
3. How you will be given Carnitor injection
4. Possible side effects
5. How to store Carnitor injection
6. Further information
1. What Carnitor injection is and what it is used for
Carnitor injection contains L-carnitine which is a type of protein. It is used to treat primary
and secondary carnitine deficiency in adults, children, infants and newborn children. It
can also be used to treat secondary carnitine deficiency in haemodialysis patients.
Carnitine deficiency occurs when the body has a shortage of L-carnitine. Carnitor injection
makes up for your bodies lack of L-carnitine and helps give your body more energy.
2. Before you are given Carnitor injection
Do not take Carnitor injection:
- if you are allergic to L-carnitine or any other ingredients in Carnitor injection. These
ingredients are listed in section 6 of this leaflet.
If this applies to you, do not take Carnitor injection.
Tell your doctor before you are given Carnitor injection if:
- you have severe kidney problems or kidney disease and are having dialysis
- you are diabetic and taking insulin, or any other drug to treat your diabetes.
If any of the above applies to you talk to your doctor or pharmacist.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or if you become pregnant
while having Carnitor injection. Your doctor will decide whether or not you should continue
to have your medicine.
If you wish to breastfeed, ask your doctor for advice.
Driving and using machines
You can drive or use machines whilst taking Carnitor injection.
3. How you will be given Carnitor injection
How much Carnitor injection will you be given
Your doctor will carefully calculate the amount of Carnitor injection that you should be
given and may vary it depending on your response to the treatment. The doctor may take
blood and urine samples to check the amount of the drug in your body.
Method of administration
Your doctor will give the injection slowly into your vein (intravenous injection) over a period
of 2-3 minutes.
Primary carnitine deficiency
The usual recommended dose is 100 mg per kg of your body weight per day. This will
be given in 3-4 doses.

Secondary carnitine deficiency in haemodialysis patients (dialysis of the blood)
A dose of 20 mg per kg of your bodyweight should be given in the same way as above
at the end of each dialysis session (assuming three sessions per week). The treatment
should last at least three months, which is the time required to restore normal muscle
levels of free carnitine. If significant benefit is seen following this first course of treatment
ongoing therapy using 1g per day of Carnitor Oral Solution may be used. On the day of
dialysis Carnitor Oral Solution should be taken at the end of the dialysis session.
If you are given more Carnitor injection than you should
If you think you have been given too much Carnitor injection tell your doctor.
If you have any further questions about taking this medicine, please ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Carnitor injection can cause side effects, although not everybody gets
them.
Side effects are:
- Drug-related body odour. Your doctor may reduce your dose to help lessen or stop the
odour.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, tell your doctor or pharmacist.
5. How to store Carnitor injection
Keep out of the reach and the sight of children.
Do not use Carnitor injection after the expiry date stated on the sealed glass ampoule.
The expiry date refers to the last day of that month.
Store below 25ÂșC and protect from light.
Medicines should not be disposed of via wastewater or in household waste. Return any
medicine you no longer need to the pharmacist.
6. Further information
What Carnitor injection contains
- The active substance is L-carnitine inner salt. Each Carnitor injection contains 1 g
L-carnitine inner salt in each 5 ml sealed glass container (ampoule).
- The other ingredients are hydrochloric acid 10% and water for injection.
What Carnitor injection looks like and contents of the pack
Carnitor injection is a clear, colourless or light straw-coloured liquid. It comes in 5 ml clear
sealed glass containers (ampoules). There are 5 ampoules in each pack of Carnitor
injection.
Marketing Authorisation Holder:
sigma-tau Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47 - 00144 Rome, Italy
Manufacturer:
sigma-tau Industrie Farmaceutiche Riunite S.p.A.
Pomezia, Italy
This leaflet was last revised in October 2008.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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